Biocon Limited an innovation-led global biopharmaceutical company, announced today that it has received approval In India for its Liraglutide drug substance, and its wholly owned subsidiary, Biocon Pharma Limited, has received approval for its Liraglutide drug product (6 mg/ml solution for injection in pre-filled pen and cartridge), from the Drugs Controller General of India, CDSCO (Central Drugs Standard Control Organisation).
The approval is for the generic version of Victoza®, indicated for the treatment of insufficiently controlled Type 2 Diabetes Mellitus in adults, adolescents and children aged 10 years and above, as an adjunct to diet and exercise. The approval was received from the CDSCO under the recently formulated 101 route that enables recognition of approvals granted by established and referenced serious regulatory authorities.
Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd, said: “The approval of our first vertically integrated GLP-1 in India, Liraglutide, is another significant step forward in expanding access of this product to patients suffering from diabetes. India has one of the highest number of people with diabetes globally, with estimates exceeding 77 million cases, and expected to rise further. The approval enables us to address a critical need by making this drug available, and aligns with Biocon’s mission to provide affordable, lifesaving medications to those who need it the most. We are now gearing up to launch the product expeditiously through our commercialization partners in India’’
With GLP-1 therapies projected to be a substantive future growth driver for Biocon, the Company remains committed to reinforcing its position as a key player in this area.
About Glucagon-like peptide-1 (GLP-1) : Glucagon-like peptide-1 (GLP-1) are medications that help lower blood sugar levels and promote weight loss. They are physiological hormones that have multiple actions on glucose, mediated by the GLP-1 receptors released from gut enteroendocrine cells and control meal-related glycemic excursions through augmentation of insulin and inhibition of glucagon secretion. GLP-1 also inhibits gastric emptying and food intake actions, maximizing nutrient absorption while limiting weight gain.
About Liraglutide : Liraglutide is a synthetic analog of GLP-1 peptide and is administered as a once-daily injection. It was approved for medical use in the European Union in 2009, and in the United States in 2010. Liraglutide was approved by the US FDA in 2014, and by the EMA a year later, for adults who are either obese or overweight with atleast one weight-related condition. In 2019, it was approved by the US FDA for the treatment of children who are ten years or older with type 2 diabetes, making it the first non-insulin drug approved to treat type 2 diabetes in children since metformin was approved in 2000.
